South Korea MFDS Launched Search Database for Herbal Medicine Related Information
The Ministry of Food and Drug Safety has launched a database of ‘National Herbal Medicine Information’ on 21 December 2020 …
South Korea MFDS to Improve the Information Disclosure Process for Drug Approval Results
The Ministry of Food and Drug Safety announced on 21 December 2020 that it will improve the information disclosure process …
Australia’s Transition for Permitted Indications for Listed Medicines Ends 5 March 2021
On 6 March 2018, the TGA implemented a list of permitted indications for medicines listed under section 26A of the …
Australia TGA Designs a New Regulatory Framework for Personalized Medical Devices (Including 3D-Printed Devices)
Under the current medical devices, regulatory framework custom-made medical devices are exempt from the requirement to be included in the …
Australia TGA’s Staged Transition to eCTD-only for Prescription Medicines from 1 November 2020
This transition will see Australia adopt best practice standards that are currently applied across the world. Providing benefits for both …
Singapore HSA Streamlines Stability Data Requirements for Therapeutic Product Registration
Singapore HSA has revised the Guidance on Therapeutic Product Registration in Singapore and Related Appendices. The changes will take effect …
Malaysia NPRA Issues Directive on Registration and Enforcement of Cell and Gene Therapy Products(CGTPs) in Stages
On 14 Dec 2020, Malaysia NPRA issues Directive 19 of 2020 on Registration And Enforcement Of Cell And Gene Therapy Products(CGTPS …
Singapore HSA Singapore Launches New Digital Health Webpage
HSA launched this webpage in December 2020 as a one-stop portal to encourage innovation in the area of digital health …
Korea MFDS announces obligation to use E2B (R3) for electronic transmission of Individual Case Safety Reports from June 2021
On 30 November 2020, the Korean Ministry of Food and Drug Safety (MFDS) has issued a press report titled “To …